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24/08/23
07:42
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Originally posted by yehudi:
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This may be of interest. The 17th Bioshares summit was recently held in Hobart, where Pachacz says there were several ASX companies discussing catalysts coming up in the next 12 to 18 months. Here’s some Pachacz thought were worth a mention. Opthea (ASX:OPT)Topping his list of stocks to watch with an upcoming key catalyst is eye disease specialist OPT. It’s conducting not one but two concurrent Phase 3 clinical trials with OPT-302 (drug name sozinibercept) for the treatment of wet age-related macular degeneration (Wet AMD) – a chronic eye disease that causes blurred vision or a blind spot in your visual field.OPT-302 has demonstrated improved efficacy above the existing standard of care in a large Phase 2b study.In its latest results OPT-302 was shown to have a novel mechanism of action and a favourable safety profile.Goldman Sachs has a buy recommendation on OPT with a 12-month target price of $2.80 versus current price of 58 cents.“It’s a bit of a sleeper because it’s doing such a long trial that started a couple of years ago but the results are due out mid next year and it could be the most significant event of the year for the sector I think,” Pachacz says.He says there are two drugs available to treat the condition currently and a third off-label, together generating ~US$16 billion annually.The FDA has granted OPT-302 fast track designation for the treatment of Wet AMD.“There’s potentially a way to get a more durable treatment so it might mean less injections because you need to get an injection to the eye every six to eight weeks,” he says.Last year OPT inked a deal with Launch Therapeutics (Launch Tx) to finance and advance the ongoing Phase 3 clinical trials and pre-commercialisation activities of OPT-302 for Wet AMD.Launch Tx is a development company backed by funds managed by global investment firm Carlyle (NASDAQ:CG) and its life sciences franchise, Abingworth.Carlyle and Abingworth, in collaboration with Launch Tx, committed to up to US$170 million for OPT.As part of the deal, if OPT-302 is approved in a major market, OPT will make a milestone payment after regulatory approval and then six subsequent annual fixed success payments and variable success payments of 7% of net sales, with cumulative payments capped at four times the amount funded to OPT.OPT retains full worldwide commercial rights for OPT-302 and has the option to prepay its obligations in full at any time.“They didn’t sell equity but a portion of future profits from the drug if it gets approved so it’s quite unique for the Australian biotech landscape,” Pachacz says.“They don’t own any shares in Opthea but they will get 25% of all the royalties up to four times what they invested.”
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=> „Results are due out mid next year ,” Pachacz says. <= Again a big flaw! As the official guidance stands at topline read-out Q1 2025 . On top, a further delay beyond Q1 2025 is definitely well in the cards with full financial year results as OPT has not yet commented on having reached the 50% enrollment threshold. So watch out for the 2022/23 AR next week .